If modifications need to be made to the study, an amendment must be submitted in the research ethics system and receive clearance before any changes are implemented.
When should an amendment be submitted?
An amendment request is normally appropriate for minor changes to an approved application. The following are examples of changes that can be made:
- adding and/or removing a research team member (e.g., co-investigator, student researcher, research assistant, etc.)
- minor changes in numbers of animals from the number initially approved;
- changes, additions or deletions of species where the procedures remain the same; and
- minor changes to procedures where the invasiveness category remains the same as that approved.
Amendments can be categorized as administrative in nature, minor or major. Major amendments are reviewed by a sub-committee of the ACC and are subject to the same submission deadlines as full applications.
When is a new application needed?
A new application will be required in the following situations:
- if the study objectives change significantly
- the modification includes the addition of a D or E category
- substantial extension/changes to endpoints for example.
Other situations may require a new application. If you are unsure whether you should submit an amendment or a new application, please contact the Manager, Research Ethics to discuss.
How to prepare and submit an amendment request
Step 1: In the research ethics system, select "Amend" from the menu on the right-hand side of the application. Any research team member given full access can start the amendment and make changes.
Step 2: In the amendment justification, briefly outline the changes that you are making and why.
Step 3: Read through the full application and update any section that is impacted by the amendment (e.g., if you are adding a new Person to the team, you would update the "People" section of the application).
Step 4: PI submits the amendment by clicking on the "Submit" button on the right-side menu. Please note that only the PI can submit new applications in the research ethics system. Other team members with full access are able to submit revisions to the applications.